AR072796A1 - VACCINE STABILIZER AND COMPOSITION THAT INCLUDES ONE OR MORE FLAVIVIRUS LIVED OR CHEMERIC. STABILIZATION METHOD KIT - Google Patents

VACCINE STABILIZER AND COMPOSITION THAT INCLUDES ONE OR MORE FLAVIVIRUS LIVED OR CHEMERIC. STABILIZATION METHOD KIT

Info

Publication number
AR072796A1
AR072796A1 ARP090102524A ARP090102524A AR072796A1 AR 072796 A1 AR072796 A1 AR 072796A1 AR P090102524 A ARP090102524 A AR P090102524A AR P090102524 A ARP090102524 A AR P090102524A AR 072796 A1 AR072796 A1 AR 072796A1
Authority
AR
Argentina
Prior art keywords
live attenuated
stabilizer
flaviviruses
vaccine
dehydrated
Prior art date
Application number
ARP090102524A
Other languages
Spanish (es)
Original Assignee
Sanofi Pasteur
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Pasteur filed Critical Sanofi Pasteur
Publication of AR072796A1 publication Critical patent/AR072796A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/24011Flaviviridae
    • C12N2770/24111Flavivirus, e.g. yellow fever virus, dengue, JEV
    • C12N2770/24151Methods of production or purification of viral material
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Virology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Communicable Diseases (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

Reivindicacion 1: Un estabilizador para composiciones de vacuna que comprende uno o más flavivirus vivos atenuados, que comprende, en una solucion acuosa sin proteínas de origen animal y sin sales agregadas que tiene: cationes divalentes; un buffer; 2,5% a 6,5% de sorbitol; 2,5% a 13% de sucrosa; 0 a 7,5% de trehalosa y/o 0 a 7,5% de cualquier otro disacárido o trisacárido; 0,2% a 0,5% de urea; 0,8% a 2,5% de una mezcla de aminoácido que comprende arginina (Arg), cistina (Cys-Cys), histidina (His), isoleucina (Ile), leucina (Leu), lisina (Lys), metionina (Met), fenilalanina (Phe), teonina (Thr), triptofano (Trp), tirosina (Tyr), valina (Val), alanina (Ala), asparagina (Asn), ácido aspártico (Asp), ácido glutámico (Glu), glicina (Gly), prolina (Pro) y serina (Ser). Reivindicacion 2: El estabilizador de acuerdo con la reivindicacion 1, que comprende uno o más buffers seleccionados entre el grupo integrado por TRIS (tris(hidroximetil)-aminometano), HEPES ácido (2-(4-(2-hidroxietil)-1-piperazinil)etano-sulfonico) y fosfato de potasio y/o fosfato de sodio. Reivindicacion 6: Una composicion de vacuna acuosa a granel estabilizada que comprende uno o más flavivirus vivos atenuados y el estabilizador segun se reivindica en una o más de las reivindicaciones 1 a 5. Reivindicacion 15: Un método para estabilizar uno o más flavivirus vivos atenuados, que comprende la dilucion de una coleccion viral purificada y concentrada que comprende uno o más flavivirus vivos atenuados mediante el agregado de estabilizador de modo de obtener las concentraciones finales del estabilizador que se definieron de acuerdo con las reivindicaciones 1 a 5 a fin de obtener una composicion de acuerdo a lo que se reivindica en una o más de las reivindicaciones 6 a 14. Reivindicacion 22: Una composicion de vacuna deshidratada que se obtuvo mediante el secado de la composicion a granel estabilizada segun se reivindica en uno o más de las reivindicaciones 6 a 14. Reivindicacion 23: La composicion de vacuna deshidrata de acuerdo con la reivindicacion 22, que se encuentra presente en la forma de partículas uniformes o de esferas. Reivindicacion 24: La composicion de vacuna deshidratada de acuerdo con la reivindicacion 23, donde cada partícula o cada esfera contiene una mezcla de diversos flavivirus vivos atenuados y/o quiméricos vivos atenuados. Reivindicacion 25: La composicion de vacuna deshidratada de acuerdo con la reivindicacion 23, donde cada partícula o cada esfera contiene flavivirus vivos atenuados y/o quiméricos vivos atenuados de un unico tipo. Reivindicacion 26: Un método para preparar una vacuna, que comprende el paso de reconstituir la composicion segun se reivindica en una de las reivindicaciones 22 a 25 con una solucion acuosa.Claim 1: A stabilizer for vaccine compositions comprising one or more live attenuated flaviviruses, comprising, in an aqueous solution without proteins of animal origin and without added salts having: divalent cations; a buffer; 2.5% to 6.5% sorbitol; 2.5% to 13% sucrose; 0 to 7.5% trehalose and / or 0 to 7.5% of any other disaccharide or trisaccharide; 0.2% to 0.5% urea; 0.8% to 2.5% of an amino acid mixture comprising arginine (Arg), cystine (Cys-Cys), histidine (His), isoleucine (Ile), leucine (Leu), lysine (Lys), methionine ( Met), phenylalanine (Phe), theonine (Thr), tryptophan (Trp), tyrosine (Tyr), valine (Val), alanine (Ala), asparagine (Asn), aspartic acid (Asp), glutamic acid (Glu), glycine (Gly), proline (Pro) and serine (Ser). Claim 2: The stabilizer according to claim 1, comprising one or more buffers selected from the group consisting of TRIS (tris (hydroxymethyl) -aminomethane), acid HEPES (2- (4- (2-hydroxyethyl) -1- piperazinyl) ethanesulfonic) and potassium phosphate and / or sodium phosphate. Claim 6: A stabilized bulk aqueous vaccine composition comprising one or more live attenuated flaviviruses and the stabilizer as claimed in one or more of claims 1 to 5. Claim 15: A method for stabilizing one or more live attenuated flaviviruses, comprising the dilution of a purified and concentrated viral collection comprising one or more live flaviviruses attenuated by the stabilizer addition so as to obtain the final stabilizer concentrations defined in accordance with claims 1 to 5 in order to obtain a composition according to what is claimed in one or more of claims 6 to 14. Claim 22: A dehydrated vaccine composition that was obtained by drying the stabilized bulk composition as claimed in one or more of claims 6 to 14. Claim 23: The dehydrated vaccine composition according to claim 22, found present in the form of uniform particles or spheres. Claim 24: The dehydrated vaccine composition according to claim 23, wherein each particle or each sphere contains a mixture of various live attenuated flaviviruses and / or live attenuated chimerics. Claim 25: The dehydrated vaccine composition according to claim 23, wherein each particle or each sphere contains live attenuated flaviviruses and / or live attenuated chimerics of a single type. Claim 26: A method of preparing a vaccine, comprising the step of reconstituting the composition as claimed in one of claims 22 to 25 with an aqueous solution.

ARP090102524A 2008-07-09 2009-07-06 VACCINE STABILIZER AND COMPOSITION THAT INCLUDES ONE OR MORE FLAVIVIRUS LIVED OR CHEMERIC. STABILIZATION METHOD KIT AR072796A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP08305390A EP2143440A1 (en) 2008-07-09 2008-07-09 Stabilising agent and vaccine composition comprising one or several attenuated living flavivirus

Publications (1)

Publication Number Publication Date
AR072796A1 true AR072796A1 (en) 2010-09-22

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ARP090102524A AR072796A1 (en) 2008-07-09 2009-07-06 VACCINE STABILIZER AND COMPOSITION THAT INCLUDES ONE OR MORE FLAVIVIRUS LIVED OR CHEMERIC. STABILIZATION METHOD KIT

Country Status (17)

Country Link
US (2) US8142795B2 (en)
EP (3) EP2143440A1 (en)
JP (1) JP5586598B2 (en)
KR (1) KR101679723B1 (en)
CN (1) CN102089002B (en)
AR (1) AR072796A1 (en)
AU (1) AU2009267401B2 (en)
BR (1) BRPI0915813B1 (en)
CA (1) CA2729758C (en)
DK (1) DK2310048T3 (en)
ES (1) ES2429130T3 (en)
IL (1) IL210289A0 (en)
MX (1) MX2011000312A (en)
MY (1) MY150613A (en)
TW (1) TWI460190B (en)
WO (1) WO2010003670A1 (en)
ZA (1) ZA201100107B (en)

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